Treatment of Portal Vein Tumor Thrombus After Hepatocellular Carcinoma Resection

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Laser ablation; Drug: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT00825669

EHBH-RCT-2008-015

Details and patient eligibility

About

Hepatectomy is still the treatment of choice for hepatocellular carcinoma. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment for PVTT yet. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.

Full description

Hepatectomy is still the treatment of choice for hepatocellular carcinoma, but the prognosis is not agreeable. Part of the patients may present portal vein tumor thrombus (PVTT) after resection. PVTT might further increase the pressure of portal vein and lead to upper gastrointestinal bleeding and worsening of hypersplenism which will endanger the life of the patients. PVTT also plays the centre role of recurrence and metastasis of HCC. There is no standard treatment available now for PVTT yet. TACE is mostly often used to treat the PVTT. We aim to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. PVTT after liver resection was diagnosed with at least two types of imaging findings, such as CT, MRI or color doplor findings.
2. The functions of the kidney, heart and lung and the routine test of the blood are in good condition.
3. The liver function is of grade A or B in Child-Pugh classification.
4. The patient is eligible of the trial and will show consent to the test.

Exclusion criteria

1. any of the parameters. WBC less than 2000/ml, Hb less than 90g/L or PLT less than 50000/ml.
2. disfunction of the heart, lung, kidney, or brain.
3. any other disease might affect the trial .
4. the patients would not sign the consent to the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

survival rate (TACE)

Active Comparator group

Description:

to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Treatment:

Drug: TACE

survival rate (TACE plus laser ablation)

Active Comparator group

Description:

to compare the effects of TACE and TACE plus laser ablation for treating patients with PVTT

Treatment:

Drug: TACE

Procedure: Laser ablation